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10.3. Hevylite standardisation

Chapter 10

As DA470k does not have assigned values for the individual light chain types of each immunoglobulin class (that are the targets of the HLC assays), it cannot be used to directly assign values to individual HLC assay calibrators. However, the sum of concentrations measured by pairs of HLC reagents (e.g. IgGκ + IgGλ) should equate to the assigned value for the corresponding total immunoglobulin (i.e. IgG). The calibration of the Hevylite assays is therefore based on this summation, and is further discussed in Section 9.4. It follows that for a particular immunoglobulin class, when the Ig’κ and Ig’λ HLC reference intervals are combined, the range of values should be equivalent to the reference interval for the corresponding total immunoglobulin.